Type of information: Milestone
Compound: investigational medicines targeting Human Cytomegalovirus (HCMV), including letermovir (AIC246)
Company: Aicuris (Germany) Merck&Co (USA)
Therapeutic area: Infectious diseases - Transplantation
Type agreement: licensing - development - commercialisation
- antiviral agent. Letermovir (AIC246) is an investigational oral, once-daily candidate for the prevention and treatment of HCMV infection. It is a potentially first in class molecule derived from a novel chemical class (quinazolines) and is designed to inhibit the HCMV viral terminase. In April 2012, AiCuris announced that a randomized, placebo controlled Phase IIb clinical trial evaluating the safety and efficacy of letermovir in HCMV-seropositive allogeneic human blood precursor cell recipients (bone marrow transplant patients) met all primary efficacy endpoints. Letermovir has received Orphan Drug Status in the European Union and the United States, where it has also been granted Fast Track Designation.
Disease: treatment and prevention of HCMV infection in transplant recipients
- • On October 15, 2012, Merck & Co and AiCuris have entered into an exclusive worldwide licensing agreement for AiCuris' novel portfolio of investigational medicines targeting Human Cytomegalovirus (HCMV), including letermovir (AIC246), an oral, late-stage antiviral candidate being investigated for the treatment and prevention of HCMV infection in transplant recipients. Under the agreement, Merck, through a subsidiary, will gain worldwide rights to develop and commercialize candidates in AiCuris' HCMV portfolio. Closing of the transaction is contingent upon obtaining clearance from the relevant authorities.
- AiCuris will receive a €110 million upfront payment and is eligible for milestone payments of up to €332.5 million based on successful achievement of development, regulatory and commercialization goals for HCMV candidates, including letermovir, an additional back-up candidate as well as other Phase I candidates designed to act via an alternate mechanism. In addition, AiCuris will be entitled to receive royalty payments reflecting the advanced stage of the clinical program on any potential products that result from the agreement, Merck will be responsible for all development activities and costs.
- • On January 31, 2018, AiCuris announced that the European Commission granted marketing authorization to Merck & Co for Prevymis™ (letermovir) for prophylaxis (prevention) of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). The EU approval triggers a milestone payment to AiCuris in the amount of € 30 million on top of the € 105 million milestone payment received already following the approval by the FDA in November 2017.